Trial document




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  DRKS00005038

Trial Description

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Title

“Stop the pain – A multicenter, randomized-controlled study of a cognitive-behavioral intervention for children with functional abdominal pain“

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Trial Acronym

Stop-FAP

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URL of the Trial

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Brief Summary in Lay Language

This trial aims to compare two training programs for children suffering functional abdominal pain. These two programs are comaprable in number of sessions and group sizes, but show differences in content (very focused on pain management vs. more general information and support).
Focus of the trial ist the evaluation of "Stop the pain", which has shown high effectivenes in one first trial. This time, five clinics, experienced in diagnosis and treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are eligible. The programs imply six weekly group session for the children and 2 parent evenings. The study group assumes that participation in "Stop the pain" will reduce pain experience and will improve the childrens' quality of life and coping strategies - up to 12 months after training.

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Brief Summary in Scientific Language

The trial aims to assess the efficacy of a cognitive- behavioral self-manegement program (intervention group, IG) compared to an equally extensive information-only control group (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral, manualized program "Stop the pain with Happy Pingu". Follow up per patient: 3- and 12 months.
Children aged 7-12 years suffering functional abdominal pain (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is that for participants in the IG the frequency and intensity of pain will be reduced more successfully and more sutainably than for children in the CG. Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG.

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Organizational Data

  •   DRKS00005038
  •   2013/07/25
  •   2014/01/07
  •   yes
  •   Approved
  •   19/2013, Ethikkommission der Universität Potsdam
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Secondary IDs

  •   NCT02030392  (ClincialTrials.gov)
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Health Condition or Problem studied

  •   pain related functional gastrointestinal disorders ("functional abdominal pain", Rome-III criteria H2a, H2b, H2d, H2d1; F 45.4 resp. F54))
  •   F45.4 -  Persistent somatoform pain disorder
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Interventions/Observational Groups

  •   Intervention group: participation in the cognitive-behavioral program "Stop the pain with Happy Pingu". The program comprises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (50 min each).
  •   active control group: participation in an information and education control group (physical well-being, health and gastrintestinal tract). The program of the control group comprises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (50 min each).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary efficacy endpoint is the frequency and intensity of pain (composite score) over the course of treatment and follow-up (pre, post, 3 and 12 months follow up).
This primary outcome will be assessed by pain diary in childrens self-report (over 2 weeks).

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Secondary Outcome

Secondary efficacy endpoints are health-related quality of life and pain-related coping and cognitions.
The secondary outcome variables will be assessed by self -report questionnare (each assessed at pre, post, 3- and 12 months follow-up). Following questionnaires are included: PedsQL, PPCI, KINDL-R. Parents report on childs quality of life (PedsQL proxy report).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/01
  •   112
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   12   Years
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Additional Inclusion Criteria

Inclusion criteria for medical screening:
- abdominal pain for at least 2 months
- abdominal pain at least once per week
- aged 7-12 years


Inclusion Criteria for study participation:
- pain-predominant functional gastrointestinal disorders according to Rome-III
- criteria (H2a, H2b, H2d, H2d1)
- informed consent
- no time constraints for participation in training groups

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Exclusion Criteria

exclusion criteria for medical screening:
very limited german language skills; mental retardation; concomitant psychological treatment; at point of screening constant physician-prescribed treatment (psychological, medical) of gastrointestinal complaints; at point of screening participation in a training program for gastroinestinal complaints during the last 6 months; at point of screening participation in a clinical trial which might have effects on abdominal pain in the last 4 weeks; presentation of sibling aged 7-12 years with abdominal pain.


Exclusion Criteria for study participation:
- psychiatric disorder (internalizing) with primary treatment indication
- severe externalizing disorder

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Addresses

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    • Universität Potsdam Department Psychologie Beratungspsychologie
    • Ms.  Prof. Dr.  Petra  Warschburger 
    • Karl-Liebknecht-Straße 24-25
    • 14476  Potsdam
    • Germany
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    • Universität Potsdam Department Psychologie
    • Ms.  Prof. Dr.  Petra  Warschburger 
    • Karl-Liebknecht-Straße 24-25
    • 14476  Potsdam
    • Germany
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    • Lehrstuhl für Beratungspsychologie Department Psychologie Universität Potsdam
    • Ms.  Prof.  Petra  Warschburger 
    • Karl-Liebknecht-Str. 24/25
    • 14476  Potsdam OT Golm
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/07
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Trial Publications, Results and other Documents

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